Background: The gold standard for the treatment of cardiac implantable electronic devices (CIEDs)-related infection and lead malfunction is transvenous lead extraction (TLE). To date, the risk of mortality directly related to TLE procedures is relatively low, but data on post-procedural and long-term mortality are limited, even more in the aging population. Methods: Consecutive patients with CIEDs who underwent TLE were retrospectively studied. The primary outcome was the endpoint of death, considering independent predictors of long-term clinical outcomes in the TLE aging population comparing patients with and without infection. Results: One hundred nineteen patients (male 77%; median age 76 years) were included in the analysis. Eighty-two patients (69%) documented infection, and thirty-seven (31%) were extracted for a different reason. Infected patients were older (80 vs. 68 years, p-value > 0.001) with more implanted catheters (p-value < 0.001). At the last follow-up (FU) available (median FU 4.1 years), mortality reached 37% of the patient population, showing a statistically significant difference between infected versus non-infected groups. At univariable analysis, age at TLE, atrial fibrillation, and anemia remained significant correlates of mortality; at multivariable analysis, only patients with anemia and atrial fibrillation have a 2.3-fold (HR 2.34; CI 1.16–4.75) and a 2.5-fold (HR 2.46; CI 1.33–4.54) increased rate of death, respectively. Conclusion: Our long-term data showed that aging patients who underwent TLE for CIED-related infection exhibit a high mortality risk during a long-term follow-up, potentially leading to a rapid and effective procedural approach in this patient population.

Background: Cardiogenic shock with acute hemodynamic decompensation may be one of the most serious risks in patients affected by ventricular tachycardia (VT). Its proper identification may have important implications in terms of pharmacological management, as might procedural planning in case of patients undergoing catheter ablation. Methods: We describe a case series of patients with provisional strategies for circulatory support in VT ablation, including the use of venoarterial extracorporeal membrane oxygenation (VA-ECMO) and vascular accesses in the electrophysiology lab but no initial ECMO activation due to an estimated intermediate pre-procedural risk from the case-series population. Results: In total, 10 patients (mean age 70 ± 11 years old, 9 males) with severe cardiomyopathy were admitted for incessant ventricular arrhythmia episodes, further diagnosis, and therapy planning; 1/10 patients (10%), documenting a PAINESD score of 14, underwent VA-ECMO cannulation due to electromechanical dissociation. All 10 patients were discharged alive. Conclusions: A pre-defined strategy before VT ablation is crucial. In our case series, the use of provisional circulatory support with VA-ECMO during incessant ablation of ventricular arrhythmia was a safe and winning alternative to upfront strategies.

Drugs for pulmonary arterial hypertension (PAH) have historically been evaluated for their efficacy in improving functional capacity and decreasing symptoms. However, these measures of treatment effect are approximate and subject to substantial variability, and therapeutic choices based on them may be aleatory. We reviewed the articles reporting the results of phase 3 PAH randomized controlled trials (RCTs) and calculated the fragility index (FI) for the outcomes exploring functional capacity and symptoms. The FI corresponds to the number of events that need to be added to the arm with the smallest number of events to make a significant result non-significant: the lower the FI, the fragile the trial with respect to the endpoint examined. For RCTs with non-significant results, we calculated the FI as the number of events that need to be removed from the investigational drug (ID) group to reach a P-value <0.05. When possible, we also computed the FI for PAH hospitalization. Data about the rate of functional/symptomatic improvement were available for 22 (63%) of 35 RCTs (Table). The ID was superior to placebo or comparator with P < 0.05 in 10 (45%) of these 22 studies. The median FI was 2 [interquartile range (IQR): 6.5], with 4 RCTs having a FI = 1 and only 2 > 10 (Table). For the 12 RCTs in which the effect of the ID was neutral (P > 0.05), the median FI was 6 (IQR 4.25) (Table). The hospitalization FI was determined for 17 (77%) of the 22 RCTs and was overall higher than the one for the functional/symptomatic outcome (median 6, IQR 8). Accessible information about the effects of PAH drugs on functional capacity and/or symptoms is published for 6 in 10 RCTs, in which very few events in one arm could have flipped the results from non-significant to significant or, more remarkably, from significant to non-significant. The evidence supporting the reduction of PAH hospitalizations as a treatment goal appears to be more robust.